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Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00596050
First received: January 7, 2008
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Condition Intervention Phase
Conscious Sedation Failure During Procedure
Drug: ketamine and midazolam
Drug: etomidate, fentanyl, and lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • OSBD-r [ Time Frame: immediate ]
    Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.


Secondary Outcome Measures:
  • Likert satisfaction scale [ Time Frame: immediate ]
    Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.

  • procedural recall [ Time Frame: immediate ]
    Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.


Enrollment: 50
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ketamine and midazolam
ketamine and midazolam
Drug: ketamine and midazolam
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
Active Comparator: etomidate and fentanyl and lidocaine
etomidate and fentanyl and lidocaine
Drug: etomidate, fentanyl, and lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose

Detailed Description:
There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 5-18 years
  • extremity fracture requiring reduction with sedation in emergency department

Exclusion Criteria:

  • allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine
  • multi-system trauma
  • history of psychosis
  • pregnancy
  • illicit drug use
  • developmental delay
  • non-english speaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596050

Locations
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Drexel University College of Medicine
Investigators
Principal Investigator: Jannet J Lee-Jayaram, M.D. Drexel University College of Medicine
  More Information

Publications:
Jay SM, Ozolins M, Elliott C, Caldwell S. Assessment of children's distress during painful medical procedures. J Health Psycho. 1983; 2: 133-147

Responsible Party: Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00596050     History of Changes
Other Study ID Numbers: 16271
Project No 1041266 ( Other Identifier: drexel )
Action No 47488 ( Other Identifier: drexel )
Detail No 240976 ( Other Identifier: drexel )
Study First Received: January 7, 2008
Last Updated: May 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Drexel University:
procedural sedation
fracture reduction
pediatric emergency medicine
etomidate
ketamine
analgesia

Additional relevant MeSH terms:
Midazolam
Fentanyl
Etomidate
Ketamine
Lidocaine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics, Opioid
Narcotics
Anesthetics, Local
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 23, 2017